Biostatistician

Purpose

The Biostatistician will support research on cell and tissue technologies through data analysis, study design, and statistical modeling. This role involves working with both small and large datasets, developing predictive models, generating effective visual representations of data, and assisting scientists with data interpretation and application.

Responsibilities

· Perform basic and advanced data analysis, including statistical tests and regression modeling

· Analyze large datasets, including -omics, imaging, and high-through-screening data

· Design study groups and determine sample sizes for research studies

· Advise scientists on study design and data collection methods

· Develop models to identify trends and make predictions based on research data

· Manage and integrate datasets, ensuring accuracy and consistency

· Generate clear data visualizations for reports, presentations, and publications

· Develop statistical analysis plans to guide data processing

· Communicate data analysis and statistical findings to research teams in a clear and actionable way

· Support publications, reports, and regulatory submissions with statistical analysis

· Stay up to date with new methods in biostatistics, data science, and computational biology

· Develop statistical sampling and statistical analysis procedures

· Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures

· Travel domestically up to 10% to attend offsite meetings, conferences, and support business initiatives

· Maintain acceptable attendance and punctuality for scheduled work hours and meetings

· Ensure completion of assigned tasks and responsibilities within defined timeframes

· Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary

· Perform other duties as assigned

Skills

· Excellent attention to detail to ensure data integrity, accuracy, and reproducibility

· Proficiency in statistical software and programming (GraphPad Prism, R, SAS, Python, etc.) for data analysis and modeling

· Strong statistical and analytical skills to work with both small and large datasets

· Ability to develop predictive models and trend analyses to support research decision-making

· Strong problem-solving skills to address challenges in data analysis and research methodologies

· Ability to interpret and communicate statistical findings to scientists and research teams

· Knowledge of regulatory guidelines for statistical analysis in biological research

· Ability to work independently or in a collaborative, multidisciplinary research environment

· Strong data visualization skills to present findings clearly and effectively

· Ability to multi-task and work in a fast-paced environment

Qualifications/Requirements

· Master’s degree or Ph.D. in Biostatistics, Statistics, Bioinformatics, Data Science, or a related field, from an accredited college or university required

· Minimum of 3 years of experience in statistical analysis and study design, preferably in biotechnology, life sciences, or biomedical research

· Experience analyzing large biological datasets, such as omics or high-throughput screening data

· Proficiency in statistical software and programming

· Strong understanding of data visualization techniques for research communication

· Publication or presentation experience in scientific journals or conferences

· Familiarity with machine learning and predictive modeling is a plus

· Bachelor’s degree with 5 years of experience in Biostatistics, or related field required may be substituted to meet Master’s and/or Ph.D. degree requirement

· Clearance of favorable background investigation required